Resuming Normal Drug andBiologics Manufacturing During the COVID-19 Public Health Emergency
Guidance for Industry
行業(yè)指南：COVID-19公共衛(wèi)生緊急事件期間恢復(fù)正常藥品和生物制品生產(chǎn)運(yùn)作
I. Introduction 概述
II. Background 背景
III. Recommendations 建議
A. Addressing Deviations From Established CGMP Activities 解決CGMP活動(dòng)偏差
B. Risk Management and Other Important Elements of a Plan To ResumeNormal Drug Manufacturing 風(fēng)險(xiǎn)管理和恢復(fù)正常藥品生產(chǎn)的其它重要因素
C. Prioritizing Activities To Resume Normal Drug Manufacturing 恢復(fù)正常藥品生產(chǎn)的優(yōu)先工作
IV. Additional Resources 其它資源
I. Introduction 概述
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA在保護(hù)美國免受諸如傳染性冠狀病毒病2019（COVID-19）等新興傳染病的威脅方面發(fā)揮著關(guān)鍵作用。FDA致力于提供及時(shí)的指導(dǎo)，以支持疫情應(yīng)對(duì)工作。
FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply.
FDA發(fā)布此指南意在COVID-19公共衛(wèi)生應(yīng)急計(jì)劃期間幫助藥品和生物制品生產(chǎn)商，并優(yōu)先考慮企業(yè)從受影響狀態(tài)過度到正常生產(chǎn)運(yùn)作期間的CGMP活動(dòng)。本指南介紹了如何評(píng)估和優(yōu)先處理在公共衛(wèi)生緊急情況下必須延遲、減少或以其他方式修改的CGMP活動(dòng)，以維持生產(chǎn)和藥品供應(yīng)。
Except as noted in thisguidance, this policy is intended to remain in effect only for the duration ofthe public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
除另有說明外，本政策僅在由HHS于2020年1月31日宣布并于1月27日生效的COVID-19公共衛(wèi)生緊急事件期間有效，包括HHS秘書處根據(jù)《公共衛(wèi)生服務(wù)法》（PHS法案）（42 USC 247d（a）（2））第319（a）（2）節(jié)進(jìn)行的任何延期。
Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25,2020 (85 FR 16949), titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR- 2020-03-25/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
鑒于此次突發(fā)公共衛(wèi)生事件，如2020年3月25日聯(lián)邦公報(bào)（85 FR 16949）中題為“提供與2019年冠狀病毒病相關(guān)的指導(dǎo)文件的過程”的公告所討論，由于FDA已確定事先公開參與該指南是不可行或不適當(dāng)?shù)?，因此本指南的?shí)施無需事先征詢公眾意見（參見《聯(lián)邦食品，藥品和化妝品法》（FD＆C法）第701（h）（1）（C）節(jié)和21 CFR 10.115（g）（2）。本指南將立即執(zhí)行，但仍需根據(jù)FDA的優(yōu)良指南規(guī)范接收建議。
In general, FDA’s guidancedocuments, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
通常，F(xiàn)DA的指導(dǎo)文件（包括本指南）并不構(gòu)成法律強(qiáng)制義務(wù)。相反，指南描述了FDA當(dāng)前對(duì)某個(gè)主題的想法，僅應(yīng)被視為建議，引用了特定的監(jiān)管或法規(guī)要求者除外。在FDA指南中使用“應(yīng)”一詞的意思是建議或推薦某事，但非強(qiáng)制。
III. Recommendations 建議
Drug manufacturers should assess the impact of the COVID-19 public health emergency on CGMP activities that were necessarily delayed, reduced, or otherwise modified in order to maintain production and the drug supply, and they should identify necessary remediations that ensure drug quality while endeavoring to return to normal manufacturing operations. FDA recognizes that in some cases, remediation activities that a manufacturer started during the public health emergency may not be completed until after the duration of the public health emergency. In such cases, the manufacturer should continue to follow the recommendations in this guidance with respect to such activities after termination of the public health emergency.
藥品生產(chǎn)商應(yīng)評(píng)估COVID-19公共衛(wèi)生突發(fā)事件對(duì)CGMP活動(dòng)的影響。為了維持生產(chǎn)和藥品供應(yīng)，這些活動(dòng)被延遲、減少或以其他方式進(jìn)行了修改。在努力恢復(fù)正常生產(chǎn)操作時(shí)，藥品生產(chǎn)商應(yīng)識(shí)別出必要的補(bǔ)救措施，確保藥品質(zhì)量。FDA認(rèn)識(shí)到，在某些情況下，生產(chǎn)商在公共衛(wèi)生突發(fā)事件期間開始的補(bǔ)救活動(dòng)可能要等到公共衛(wèi)生突發(fā)事件發(fā)生之后才能完成。在這種情況下，生產(chǎn)商應(yīng)在公共衛(wèi)生突發(fā)事件終止后繼續(xù)遵循本指南中有關(guān)此類活動(dòng)的建議。
If a drug manufacturer departed from established CGMP activities impacted by the COVID-19 public health emergency, the drug manufacturer should identify these deviations and any necessary remediation actions (see section III(A) below). The drug manufacturer should evaluate these actions as part of their risk management approach (see section III(B)). The results of the evaluation will help the drug manufacturer prioritize resumption activities (see section III(C)).
如果藥品生產(chǎn)商受COVID-19公共衛(wèi)生突發(fā)事件影響偏離了既定CGMP活動(dòng)，則藥品生產(chǎn)商應(yīng)確定這些偏差和任何必要的補(bǔ)救措施（見第III（A）節(jié)）。藥品生產(chǎn)商應(yīng)評(píng)估這些措施，作為其風(fēng)險(xiǎn)管理方法的一部分（見第III（B）節(jié)）。評(píng)估結(jié)果將有助于藥物生產(chǎn)商確定恢復(fù)活動(dòng)的優(yōu)先級(jí)別（見第III（C）節(jié)）。
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